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IBD Neoplasia Surveillance Pilot RCT (IBDDysplasia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067778
Recruitment Status : Completed
First Posted : August 26, 2019
Last Update Posted : March 31, 2023
Sponsor:
Collaborators:
Health Sciences Centre, Winnipeg, Manitoba
Western University, Canada
University of Toronto
Hamilton Health Sciences Corporation
Thunder Bay Regional Health Sciences Centre
Eastern Health
McGill University Health Centre/Research Institute of the McGill University Health Centre
Providence Health & Services
Royal Jubilee Hospital
University of Alberta
MOUNT SINAI HOSPITAL
Nova Scotia Health Authority
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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Brief Summary:
To determine if random biopsies can be safely eliminated from screening of average risk persons with IBD, the investigators propose to carry out a pilot randomized control trial in which targeted biopsies in combination with random biopsies will be compared to targeted biopsies alone in terms of pre-cancerous lesion capture rate, side-effects and CRC risk. The pilot study will aim to capture 20% of the overall study population in order to evaluate the feasibility of recruiting the needed number of participants in the specified time frame, while maintaining high quality of data collection.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Colonic Neoplasms Dysplasia Diagnostic Test: Intervention Group Diagnostic Test: Control Group Not Applicable

Detailed Description:

Inflammatory Bowel Disease (IBD), including crohn's disease and ulcerative colitis, is a group of diseases characterized by acute and chronic inflammation of the intestinal tract. Persons with IBD are at an increased risk of developing colorectal cancer (CRC) and require frequent CRC screening with colonoscopy. Current IBD screening guidelines recommend the taking of biopsies of any lesions suspected to be pre-cancerous (targeted biopsies), as well as the taking of 30 to 40 random biopsies throughout the colon. The recommendations for random biopsies are based on historical practice and the theory that they would capture "invisible lesions", but are not supported by strong scientific evidence.

In fact, recent evidence has shown that random biopsies capture a very small number of pre-cancerous lesions and that they capture such lesions only in persons with additional risk factors for CRC. In addition, new colonoscopy practices and technology have made 80-90% of pre-cancerous lesions visible. Random biopsies also carry potential risks for patients, including lower gastrointestinal bleeding and bowel perforation, and substantially increase procedural costs and time.

Hence, there is a strong impetus to conduct a well-powered non-inferiority Randomized Controlled Trial (RCT) on this topic in a Canadian setting. With the support of a pan-Canadian IBD clinical trials alliance (the Canadian IBD Research Consortium (CIRC)), and the high prevalence of IBD in Canada, Canadian investigators are well-positioned to undertake such a trial. Before embarking on a large multi-center trial, a one-year pilot feasibility trial will be conducted to ensure that patients can be enrolled efficiently with excellent protocol compliance. A feasibility trial will also provide a crude estimate of the neoplasia detection rate (primary outcome) among persons with colon IBD (cIBD) in Canada, which will allow refinement of the sample size, recruitment period and budget for a definitive trial. To-date, no well-powered or North American RCTs have evaluated random biopsies as an intervention to guide our estimates for a definitive trial.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomized, Parallel-Group, Non-Inferiority Trial Comparing Random AND Targeted Biopsies to Targeted Biopsies Alone for Neoplasia Screening in Adult Persons With Colonic Inflammatory Bowel Diseases: A Pilot Study
Actual Study Start Date : November 6, 2020
Actual Primary Completion Date : September 20, 2022
Actual Study Completion Date : October 6, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group
Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any pre-cancerous lesions observed by the doctor) and/or removal of any polyps will be undertaken.
 Diagnostic Test: Intervention Group
Standard colonoscopy with targeted biopsies only
Control Group
Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40) and targeted biopsies (and/or removal of any polyps) will be undertaken.
 Diagnostic Test: Control Group
Standard colonoscopy with random AND targeted biopsies


Outcome Measures
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Primary Outcome Measures :
  1. Overall Number of Participants Enrolled [ Time Frame: 1 year ]
    Number of participants enrolled within one year from the overall total required.

  2. Rate of Protocol Adherence [ Time Frame: 1 year ]
    Rate of protocol adherence of major protocol violations on a per-patient basis.

  3. Rate of overall neoplasia detection [ Time Frame: 1 year ]
    Overall neoplasia detection rate for the definitive trial.

  4. Adverse Events occurrence [ Time Frame: 2 weeks ]
    Occurrence of serious and minor post-procedural adverse events within 2 weeks of procedure.


Secondary Outcome Measures :
  1. Rate of Study Variables [ Time Frame: 1 year ]
  2. Rate of Missed 2-Week Post-Procedural Assessment for Complications [ Time Frame: 2 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years old
  • Historical endoscopic/histologic disease extending beyond the rectum in UC or involving ≥ 1/3 of colorectum in CD
  • > 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in UC, ≥1/3 colorectum in CD
  • cIBD ≥ 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis)

  • In symptomatic remission at time of colonoscopy

    • For CD: Harvey-Bradshaw Index < 541
    • For UC or IBDU: Partial Mayo Score ≤ 242
  • Major purpose of colonoscopy is neoplasia screening/surveillance
  • Undergoing colonoscopy with high-definition white light endoscopy

Exclusion Criteria:

  • Persons who cannot or are unwilling to provide informed consent
  • Persons with a history of colorectal cancer
  • Persons with prior subtotal or total colectomy (> 50% of colon removed)
  • Persons undergoing colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year
  • Persons undergoing pancolonic chromoendoscopy
  • Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Boston Bowel Preparation Score of 0 or 1 in any segment)
  • Incomplete colonoscopy (unable to reach cecum)
  • Moderate-to-severe inflammation (Mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (Mayo 1) involving ≥ 50% of colorectum
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067778


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Pacific Digestive Health / Royal Jubilee Hospital
Victoria, British Columbia, Canada
Canada, Manitoba
University of Manitoba, Health Sciences Centre
Winnipeg, Manitoba, Canada
Canada, NFLD
Eastern Regional Health Authority
St. John's, NFLD, Canada, A1B 3V6
Canada, Nova Scotia
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Canada, Ontario
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, L8L 8E7
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Canada, Quebec
McGill University Health Centre
Montreal, Quebec, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
Health Sciences Centre, Winnipeg, Manitoba
Western University, Canada
University of Toronto
Hamilton Health Sciences Corporation
Thunder Bay Regional Health Sciences Centre
Eastern Health
McGill University Health Centre/Research Institute of the McGill University Health Centre
Providence Health & Services
Royal Jubilee Hospital
University of Alberta
MOUNT SINAI HOSPITAL
Nova Scotia Health Authority
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04067778    
Other Study ID Numbers: 20190428-01T
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: March 31, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
IBD
Dysplasia
Biopsy
Colonoscopy
Additional relevant MeSH terms:
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Colonic Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Neoplasms
 Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases